MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 PIPELINE FLEX INTRACRANIAL ANEURYSM FLOW DIVERTER

Model Number PED-475-10

Device Problems Break (1069); Unintended Movement (3026)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/20/2019

Event Type  malfunction  

Manufacturer Narrative

The device has been received and device evaluation anticipated, but not yet begun. Upon completion of the device evaluation a supplemental report will be filed. Related mdrs for this event: 2029214-2019-00892. If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information that a pipeline flex device did not open at the distal segment during a procedure. Second pipeline flex device tip broke of the pushwire. The patient underwent embolization treatment for an unruptured saccular aneurysm located in left cavernous segment. Measuring 8mmx5mm, landing zone distal 4. 5mm proximal 3. 5mm. The vessel was moderately tortuous. It was reported that the guidecatheter was placed through the max sheath and placed into the petrous segment for support. The medtronic microcatheter was placed into the middle cerebral artery (mca) and the first device was advanced through the catheter. The pipeline flex device advanced normally but the device failed to open distally. The device was re-sheathed several times in an effort to get the device to open. After several attempts the device was removed and a new device was inserted. The second pipeline device (same lot number) was advanced through the same catheter to the tip of the catheter. The pipeline device was deployed per ifu and as the device was being dragged back into position, the distal end of the pipeline fell into the aneurysm. The pipeline was constrained to allow the device to be advanced again and resistance was noticed while the pipeline was being re-sheathed. The resistance changed suddenly, and it was noticed that the tip wire was disconnected from the delivery system. The physician removed the delivery system, catheter and guide catheter as a unit and all parts of the system were removed successfully without incident. It should be noted that the pipeline device was found in the guide catheter and the tip wire had to be removed from the femoral sheath with hemostats. The physician then completed the case using a non-medtronic stent and coils. There were not any patient symptoms or complications associated with this event. No patient injury was reported. Patient was treated with stent/coil and was angiographically fine post procedure.

• Brand Name: PIPELINE FLEX
• Type of Device: INTRACRANIAL ANEURYSM FLOW DIVERTER
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• Manufacturer (Section G): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• Manufacturer Contact: katcha taylor ; 9775 toledo way; irvine, CA 92618 ; 7635263305
• MDR Report Key: 8955979
• MDR Text Key: 168451691
• Report Number: 2029214-2019-00893
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P100018.S011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 09/18/2019

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 09/03/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 04/18/2022
• Device Model Number: PED-475-10
• Device Lot Number: A817769
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/27/2019
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 09/09/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/19/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial